Presentation on theme: "DEFER STUDY: 5-YEAR FOLLOW-UP A Multicenter Randomized Study"— Presentation transcript:
1 DEFER STUDY: 5-YEAR FOLLOW-UP A Multicenter Randomized Study to Compare Deferral Versus Performance of PCIof Non-Ischemia-Producing StenosesPrincipal investigatorsNico H.J. Pijls, MD, PhDCatharina HospitalEindhoven, The NetherlandsBernard De Bruyne, MD, PhDCardiovascular Center AalstAalst, Belgium
2 NOTEAny treatment in health care should be directedeither toReleave symptoms ( improve functional class )or toImprove outcome ( prognosis, longevity)No other justification for any treatment is possible !
3 and prognosis (outcome) DEFER study: background (1)In patients with coronary artery disease,the most important factor with respect to bothfunctional class (symptoms)and prognosis (outcome)Is the presence and extent of inducible ischemia(many invasive & non-invasive studies in > 100,000 patients)If a stenosis is responsible for reversibleischemia, revascularization improves symptoms(if present) and outcome…..
4 DEFER study: background (2) If a stenosis is responsible for reversibleischemia, revascularization is justified…………But what if a stenosis or “plaque” isNOT responsible for reversible ischemia ?(functionally “non-significant” , “non-culprit”)PCI is often performed in such lesions,yet the benefit of such treatment is not clear
5 158 vb38/interm.RCA/Buddem (1) female, 58-y-oldunderwent PCI of severe LCX lesion a minute before50 % stenosis in mid RCAShould this lesion be stented ??158 vb38/interm.RCA/Buddem (1)
6 DEFER study: background (3) Fractional Flow Reserve, calculated fromcoronary pressure measurement, is an accurate,invasive, and lesion-specific index to demonstrateor exclude whether a particular coronary stenosiscan cause reversible ischemia.FFR can be determined easily, in the cath-lab,immediately prior to a planned interventionFFR based strategy for PCI in equivocal stenosis( DEFER – Study)
7 prospective randomized multicentric trial The DEFER Study: Designprospective randomized multicentric trial(14 centers) in 325 patients with stablechest pain and an intermediate stenosiswithout objective evidence of ischemiaAalstAmsterdamEindhovenEssenGothenborg HamburgLiègeMaastrichtMadridOsakaRotterdamSeoulUtrechtZwolledata collection & analysis:Jan Willem Bech, MD, PhDPepijn van Schaardenburgh, MD
8 The DEFER Study: Objectives Primary objectiveto test safety of deferring PCI of stenosesnot responsible for inducible ischemia asindicated by FFR > 0.75 ( “outcome” )Secondary objectiveto compare quality of life in such patients,whether or not treated by PCI(CCS-class, need for anti-anginal drugs)(“symptoms”)
9 Patients scheduled for PCI without Proof of Ischemia (n=325) The DEFER Study: Flow ChartPatients scheduled for PCI without Proof of Ischemia (n=325)Randomizationdeferral of PTCA(167)performance of PTCA (158)FFR < 0.75(68)PTCAFFR 0.75(91)FFR < 0.75(76)FFR 0.75(90)No PTCAPTCAPTCADEFER GroupREFERENCE GroupPERFORM Group
10 THE DEFER STUDY: RANDOMIZATION deferral of PCIperformance of PCI1 : 1 randomizationIf FFR < performance anywayreference groupIf FFR > randomization followeddefer PCI perform PCI
11 The DEFER Study: Catheterization 6 or 7 F guiding catheter for measurement ofaortic pressure ( Pa)QCA from 2 orthogonal viewsCoronary pressure measurement (Pd ) by0.014” pressure wire (Radi Medical Systems)Maximum hyperemia by i.v. adenosine (140 ug/kg/min)Calculation of Fractional Flow Reserve by:FFR = Pd / Pa
12 The DEFER Study: Base line data Randomized to Randomized toDeferral of PTCA Performance of PTCAN= N=158Age, (yr) 62 10Female sex (%)Ejection Fraction (%) 67 9Diabetes (%)Hypertension (%)Hyperlipidemia (%)Current Smoker (%)Family History CAD (%)
13 The DEFER Study: Baseline QCA and FFR Ref. diam. (mm) ± ± 0.57MLD (mm) ± 0.40DS (%) ± 101.42 ± 0.3852 ± 11Randomized to Randomized toDeferral of PTCA Performance of PTCAN= N=158FFR 0.190.730.19All baseline characteristics were identical between both groups
14 Diameter Stenosis versus FFR The DEFER Study:Diameter Stenosis versus FFR
15 event – free survival (%) 1007578.872.764.450Deferp=0.52Performp=0.03p=0.1725Reference(FFR < 0.75)12345Years of Follow-upNo. at riskDefer group908582747372Perform group8878706765Reference gr13510510396
16 DEFER: Clinical Outcome at 5 Years FFR ≥0.75FFR<0.75DeferPerformReferenceNumber of patients9190144Lost to follow-upCardiac Death(%)3 (3.3)2 (2.3)8 (6.0)Non Cardiac Death(%)3 (3.3)3 (3.4)4 (3.0)Q wave MI (%)4 (4.5)6 (4.5)Non-Q wave MI(%)1 (1.1)7 (5.2)CABG(%)1 (1.1)4 (4.5)14 (10.4)TLR(%)8 (8.9)8 (9.1)18 (13.4)11 (8.2)6 (6.8)6 (6.7)Non-TLR(%)Other (%)1 (1.1)2 (1.5)Total events21297052 (39 %)24 (27 %)19 (21 %)Patients ≥1 event (%)Pts free of angina(%)68 %58 %72 %
17 Cardiac Death And Acute MI After 5 Years P< 0.03%20P< 0.00515.715P=0.20107.953.3DEFER PERFORM REFERENCEFFR > FFR < 0.75
19 DEFER: Summary and Conclusions (1) In patients with stable chest pain, the most important prognostic factor of a given coronary artery stenosis, is its ability of inducing myocardial ischemia (as reflected by FFR < 0.75)In those patients, clinical outcome of such “ischemic” stenosis, even when treated by PCI, is much worse than that of a functionally “non-significant” stenosis.3. The prognosis of “non-ischemic” stenosis (FFR > 0.75) is excellent and the risk of such “non-significant” stenosis or plaque to cause death or AMI is < 1% per year, and not decreased by stenting
20 DEFER: Summary and Conclusions (2) Stenting a “non-ischemic” stenosis does not benefit patients with stable chest pain, neitherin prognostic nor symptomatic respect.
21 event – free survival (%) 10075.87564.450FFR0.75p=0.03FFR < 0.752512345Years of Follow-upNo. at riskFFR ≥ 0.75178162154143138136FFR < 0.75135105103969088